PURPOSE: The purpose of this study was to compare standard 2.0-mm monocortical plates to 2.0-mm locking plates in the treatment of mandible fractures. PATIENTS AND METHODS: A prospective randomized clinical trial was conducted at Harborview Medical Center in Seattle, WA, from January 1, 2002, to February 1, 2003, to compare 2.0-mm locking plates to 2.0-mm standard plates in treating consecutive mandible fractures. Patients were randomly assigned to receive locking 2.0-mm plates (group A) or nonlocking 2.0-mm plates (group B). Complications were divided into major and minor categories. Each complication was analyzed according to which plate was used and where the fracture occurred. The number of days from injury to operation, average age, gender, American Society of Anesthesiologists (ASA) classification,compliance, and social habits were all reviewed. RESULTS:Ninety patients with 122 fractures met the inclusion criteria. Sixty-four fracture sites were treated with locking plates and 58 with standard plates. A total of 6 complications occurred: 2 occurred at the angle, 3 at the parasymphysis, and 1 at the body. Three complications occurred in the locking group and 3 in the standard group with complication rates equaling 4.6% and 5.2%, respectively. When comparing the overall complication rates according to plates used, the Fisher exact test showed no statistically significant difference between the locking and standard plates (P = .90). The 95% confidence interval for the odds ratio is from 0.1 to 7. CONCLUSION:Mandible fractures treated with 2.0-mm locking plates and standard 2.0-mm plates present similar short-term complication rates.
RCT Entities:
PURPOSE: The purpose of this study was to compare standard 2.0-mm monocortical plates to 2.0-mm locking plates in the treatment of mandible fractures. PATIENTS AND METHODS: A prospective randomized clinical trial was conducted at Harborview Medical Center in Seattle, WA, from January 1, 2002, to February 1, 2003, to compare 2.0-mm locking plates to 2.0-mm standard plates in treating consecutive mandible fractures. Patients were randomly assigned to receive locking 2.0-mm plates (group A) or nonlocking 2.0-mm plates (group B). Complications were divided into major and minor categories. Each complication was analyzed according to which plate was used and where the fracture occurred. The number of days from injury to operation, average age, gender, American Society of Anesthesiologists (ASA) classification,compliance, and social habits were all reviewed. RESULTS: Ninety patients with 122 fractures met the inclusion criteria. Sixty-four fracture sites were treated with locking plates and 58 with standard plates. A total of 6 complications occurred: 2 occurred at the angle, 3 at the parasymphysis, and 1 at the body. Three complications occurred in the locking group and 3 in the standard group with complication rates equaling 4.6% and 5.2%, respectively. When comparing the overall complication rates according to plates used, the Fisher exact test showed no statistically significant difference between the locking and standard plates (P = .90). The 95% confidence interval for the odds ratio is from 0.1 to 7. CONCLUSION: Mandible fractures treated with 2.0-mm locking plates and standard 2.0-mm plates present similar short-term complication rates.